Ovary CancerNo-StomaNCT07213193
No-Stoma Policy in Advanced Ovarian Cancer Surgery
A study testing colon-rectal resection in people with Ovary Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Resection of the sigmoid-rectum is a procedure frequently required in cytoreductive surgery for advanced ovarian cancer, and it is also among the procedures with the highest risk of complications. One of the major, albeit uncommon, complications of intestinal anastomosis is anastomotic leakage. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- colon-rectal resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 20 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with suspected or anatomopathological diagnosis of malignant ovarian tumor undergoing elective primary or secondary cytoreduction and needing rectosigmoid resection and anastomosis
- Informed consent signed prior to performing any procedure related to the clinical trial
- Age 18 years old.
Who cannot join
- Patients with histologies other than ovarian tumor.
- Only palliative surgery planned
- Patients who do not require sigmoid-rectum resection after intraoperative evaluation
- Patients who do not receive colorectal anastomosis and undergo end ostomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica
Roma, 00168
VIRGINIA VARGIU, +393387106039, virginia.vargiu@policlinicogemelli.it
Virginia Vargiu
About this study
Official title: No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes
Resection of the sigmoid-rectum is a procedure frequently required in cytoreductive surgery for advanced ovarian cancer, and it is also among the procedures with the highest risk of complications. One of the major, albeit uncommon, complications of intestinal anastomosis is anastomotic leakage. According to the literature, the rate of anastomotic leakage following cytoreductive surgery for ovarian cancer ranges from 1.7% to 17%.
The risk factors associated with this complication are varied and often inconsistent across studies. They range from preoperative clinical conditions-such as age, low albumin levels, and Body Mass Index < 18-to intraoperative factors such as low to mid rectal resection, high ligation of the inferior mesenteric artery, and multiple bowel resections.
Read more
Apart from the rehabilitative programs introduced by the Enhanced Recovery After Surgery protocol-which aim to improve the nutritional status of patients undergoing cytoreductive surgery for ovarian cancer-we currently lack validated tools to reduce the risk of leakage. The most commonly used strategy remains the creation of a protective stoma. However, several studies have shown that this procedure is not actually a protective factor against anastomotic leakage; rather, its utility lies in mitigating the severity of the complication.
Nonetheless, stomas have a significant clinical and psychological impact, with complication rates ranging from 33.9% to 45% and reversal rates between 66.5% and 89%.
This study aims to evaluate the feasibility of a no-stoma strategy in a selected "low-risk" population for anastomotic leakage among patients undergoing cytoreductive surgery for primary or recurrent ovarian cancer. Focusing on the goal of achieving a zero stoma rate, the study will provide valuable insights into the utility and outcomes of stoma creation. The results will support more informed and patient-centered clinical decisions in the management of ovarian cancer.
- Conditions
- Ovary Cancer
- Being tested
- colon-rectal resection
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colon-rectal resectionProcedure or surgery
The patients who underwent colon rectal resection, would be evaluated for stomia or not.
| Study group | Role | What they receive |
|---|---|---|
| Women with ovarian cancer | Experimental | Patients women who underwent colon rectal resection Receives: Procedure: colon-rectal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors
The feasibility of a no-stoma policy will be assessed by calculating the rate of anastomotic dehiscence in low-risk patients (who therefore did not receive a diverting stoma) and comparing these results with published data from the literature.
Measured: Intraoperative and postoperative follow-up period (90 days postoperative)
Secondary outcomes (4)
Risk Factors for Anastomotic Leak
Identification of preoperative and intraoperative variables associated with anastomotic leak using a multivariable logistic regression model.
Measured: preoperative, intraoperative
Rate of Occult Anastomotic Leak in Patients With Diverting Ostomy
Proportion of asymptomatic patients with diverting ostomy presenting with occult anastomotic leak, as assessed by water-soluble rectal contrast enema performed between postoperative days 5 and 10.
Measured: Postoperative days up to 20.
Management Strategies for Anastomotic Leak
Description and distribution of management strategies for anastomotic leak (conservative vs. non-conservative), stratified by low- and high-risk patient groups, and evaluation of the role of ostomy in leak management.
Measured: Postoperative period (up to 90 days).
Impact of Bowel Surgery on Quality of Life
Change in quality of life and bowel function, as measured by:
Gastrointestinal Quality of Life Index (GIQLI) in all patients STOMA questionnaire in patients with diverting ostomy Low Anterior Resection Syndrome (LARS) score Knowles-Eccersley-Scott-Symptom (KESS) questionnaire All questionnaires will be administered preoperatively and at 3 and 6 months post-surgery.
Measured: Baseline (pre-surgery), 3 months, and 6 months post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start1 May 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion20 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 395 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Vargiu, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213193
- Sponsor's protocol ID
- 7620
- Acronym
- No-Stoma
- Status last verified
- May 2025
- First submitted
- 4 Jun 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No-Stoma Policy in Advanced Ovarian Cancer Surgery, Feasibility and Outcomes
- ClinicalTrials.gov ID
- NCT07213193
- Acronym / sponsor ID
- No-Stoma / 7620
- Conditions
- Ovary Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 395 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 20 Dec 2028 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Resection of the sigmoid-rectum is a procedure frequently required in cytoreductive surgery for advanced ovarian cancer, and it is also among the procedures with the highest risk of complications. One of the major, albeit uncommon, complications of intestinal anastomosis is anastomotic leakage. According to the literature, the rate of anastomotic leakage following cytoreductive surgery for ovarian cancer ranges from 1.7% to 17%.
The risk factors associated with this complication are varied and often inconsistent across studies. They range from preoperative clinical conditions-such as age, low albumin levels, and Body Mass Index < 18-to intraoperative factors such as low to mid rectal resection, high ligation of the inferior mesenteric artery, and multiple bowel resections.
Apart from the rehabilitative programs introduced by the Enhanced Recovery After Surgery protocol-which aim to improve the nutritional status of patients undergoing cytoreductive surgery for ovarian cancer-we currently lack validated tools to reduce the risk of leakage. The most commonly used strategy remains the creation of a protective stoma. However, several studies have shown that this procedure is not actually a protective factor against anastomotic leakage; rather, its utility lies in mitigating the severity of the complication.
Nonetheless, stomas have a significant clinical and psychological impact, with complication rates ranging from 33.9% to 45% and reversal rates between 66.5% and 89%.
This study aims to evaluate the feasibility of a no-stoma strategy in a selected "low-risk" population for anastomotic leakage among patients undergoing cytoreductive surgery for primary or recurrent ovarian cancer. Focusing on the goal of achieving a zero stoma rate, the study will provide valuable insights into the utility and outcomes of stoma creation. The results will support more informed and patient-centered clinical decisions in the management of ovarian cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with ovarian cancer | Experimental | Procedure: colon-rectal resectionPatients women who underwent colon rectal resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with suspected or anatomopathological diagnosis of malignant ovarian tumor undergoing elective primary or secondary cytoreduction and needing rectosigmoid resection and anastomosis
- Informed consent signed prior to performing any procedure related to the clinical trial
- Age 18 years old.
Key exclusion criteria (4 listed)
- Patients with histologies other than ovarian tumor.
- Only palliative surgery planned
- Patients who do not require sigmoid-rectum resection after intraoperative evaluation
- Patients who do not receive colorectal anastomosis and undergo end ostomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colon-rectal resectionThe patients who underwent colon rectal resection, would be evaluated for stomia or not. | Procedure or surgery | Women with ovarian cancer |
Primary outcome
Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors
Time frame: Intraoperative and postoperative follow-up period (90 days postoperative)
The feasibility of a no-stoma policy will be assessed by calculating the rate of anastomotic dehiscence in low-risk patients (who therefore did not receive a diverting stoma) and comparing these results with published data from the literature.
4 secondary outcomes
Risk Factors for Anastomotic Leak
Time frame: preoperative, intraoperative
Rate of Occult Anastomotic Leak in Patients With Diverting Ostomy
Time frame: Postoperative days up to 20.
Management Strategies for Anastomotic Leak
Time frame: Postoperative period (up to 90 days).
Impact of Bowel Surgery on Quality of Life
Time frame: Baseline (pre-surgery), 3 months, and 6 months post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginia Vargiu principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colon-rectal resection in people with Ovary Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virginia Vargiu (+393387106039, virginia.vargiu@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors (time frame: Intraoperative and postoperative follow-up period (90 days postoperative)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.